JKS Newsletter Japanese regulatory documents online -July/August 2003


Jouhou Koukai Services LLC

JKS Newsletter - July/August 2003

JKS Document Store

For the first time Japanese regulatory documents - fully translated in English are made accessible for worldwide online download. The Jouhou Koukai Services is pleased to announce the opening in June of the online document store. At present the store has two departments:

Medicinal Products Lifecycle - where the available documents are arranged along the twelve stages of the drug lifecycle under the Japanese regulatory system.
Japan Monitor - containing lists and other regular updates of information related to the Japanese pharmaceuticals and medical devices regulatory affairs.

To enter the JKS Document Store please click here.

New in the JKS Document Store

Japanese regulatory documents May 2003 - full list
For the first time the entire list of all documents released by the Japanese pharmaceutical affairs authorities - containing more than 200 titles is offered in English. This document available in Japan Monitor is the first of the series of monthly lists to be released regularly in the future by JKS. The May 2003 list is now available at a special promotional price.
Japan-EU Mutual Recognition Agreement (MRA) - update June 30, 2003 - The fullest collection of documents related to the Sectoral Annex on Good Manufacturing Practice (GMP) of Medicinal Products, including the announcements from the latest meeting held on June 30, 2003.
Japanese Guideline on Impurities in New Drug Substances - update June 24, 2003 - The latest update of the Guideline on the impurities in the medicinal products with new active ingredients enforced by the PFSB/ELD Notification No. 0624001.

Update of Japan Approval Database (JAD)

Available in the JAD is the list of medicinal products recommended for regulatory approval in July. Scheduled for approval in July also are 35 generic versions of Sankyo's Pravastatin , which patent in Japan expired earlier this year.

Email enquiries:

regulatory(at)jouhoukoukai.com / orders(at)jouhoukoukai.com

International contacts:

Fax: +81-353-253-131 Tel: +81-353-253-548

Jouhou Koukai Services LLC was established in 2001 to provide services under the Law Concerning Access to Information Held by Administrative Organs enforced in Japan on April 1, 2001.The Law - also known as an equivalent to the US Freedom of Information Act (FOIA) and considered of significant interest for the worldwide healthcare, pharmaceutical, biotechnological, medical devices and allied industries.

You have received this newsletter as a service from JKS LLC. To send comments or to unsubscribe from this newsletter, send a reply to JKS LLC.